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Educating Nurses About Venous Thromboembolism (VTE) Prevention

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ClinicalTrials.gov Identifier: NCT02301793
Recruitment Status : Completed
First Posted : November 26, 2014
Results First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

As part of mandatory on-going nursing education, the investigators have incorporated identical information into two distinct web-based learning formats - the traditional linear PowerPoint format (with voice-over) and a new interactive format developed with central nursing education.

The investigators will cluster randomize nurses by floor to receive either the traditional education or the new interactive education, and evaluate the impact on administration of VTE prophylaxis doses administered by nurses before and after education. All nurses on a floor will receive the same educational format. If one method of education results in statistically significant improvement in VTE prophylaxis administration, the investigators will cross over to deliver the superior education format to all nurses who originally were given the less effective method.


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Venous Thrombosis Behavioral: Nurse education in contemporary format Behavioral: Nurse education in traditional format Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 933 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One arm was provided linear static education (Static) using PowerPoint slides with voiceover to cover the concepts. The other arm was provided interactive learner-centric dynamic scenario-based education (Dynamic), where each scenario resulted in either positive reinforcement or corrective feedback with an opportunity to apply knowledge to a new scenario.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Within strata, a coin toss (ERH) was used to randomize floors into either the Dynamic education arm or the Static education arm. Based on the outcome of the coin toss, nurses were then remotely assigned the online education module by an institutional nurse educator (DLS). The assigned educational module then appeared in the nurse's list of education assignments for completion within the institutional Learning Management System. Nurses are required to complete clinically relevant education regularly as part of ongoing professional practice and a waiver of consent was provided by the IRB; therefore nurses were not aware of their participation in a trial nor were they aware that two education modules existed. Additionally, the VTE prophylaxis medication non-administration dataset provided to the biostatistical team (i.e. outcomes assessors) for analysis was blinded by treatment arm and department.
Primary Purpose: Prevention
Official Title: Educating Nurses About Venous Thromboembolism Prevention
Actual Study Start Date : April 1, 2014
Actual Primary Completion Date : March 31, 2015
Actual Study Completion Date : March 31, 2015

Arm Intervention/treatment
Experimental: Contemporary Education Format

Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format.

Intervention: Nurse education in contemporary format

Behavioral: Nurse education in contemporary format
Education about VTE was delivered through a web-based contemporary interactive format

Active Comparator: Traditional Education Format

Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over.

Intervention: Nurse education in traditional format

Behavioral: Nurse education in traditional format
Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.




Primary Outcome Measures :
  1. Non Administration of Prescribed VTE Prophylaxis Medication Doses [ Time Frame: (Baseline); approximately 3 months later (Post-Education) ]
    This is the percentage of VTE prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse


Secondary Outcome Measures :
  1. Rates of All VTE Among Hospitalized Patients [ Time Frame: 3-12 months after end of study ]
    Did the intervention decrease rates of VTE among hospitalized patients?

  2. Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients [ Time Frame: 3-12 months after end of study ]
    Did the intervention decrease rates of DVT among hospitalized patients?

  3. Rates of Pulmonary Embolism (PE) Among Hospitalized Patients [ Time Frame: 3-12 months after end of study ]
    Did the intervention decrease rates of PE among hospitalized patients?

  4. Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal [ Time Frame: Baseline; approximately 3 months later (post education) ]
    Did the intervention decrease rates of patient refusal of VTE prophylaxis medication doses among hospitalized patients?



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nurses on selected surgical and medical floors at Johns Hopkins Hospital

Exclusion Criteria:

  • Nurses who were not permanently associated with one of the 21 hospital floors (e.g. traveling nurse, float nurse) were excluded from this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301793


Locations
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United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Elliott R Haut, MD PhD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02301793     History of Changes
Other Study ID Numbers: NA_00043860
First Posted: November 26, 2014    Key Record Dates
Results First Posted: May 17, 2019
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases